“Clinically Relevant Dissolution Specifications – Why, What, and How ?”
Speakers: Dr Paul Dickinson – SEDA Pharmaceutical Development Services and Dr Andreas Abend – MSD
Developing and registering clinically relevant dissolution specifications has been the subject of much discussion and debate for formulation, analytical and regulatory scientists for several years. Recent workshops and literature which have focused on the topic suggest certainly progress and evolution in the area as industry and regulators learn from working “hands on’ with CRDS, however some work remains to reach an agreed scientific framework to routinely establish such specifications for oral immediate-release (IR) drug products and to realise its full potential.
This webinar will set the stage for our seminar series and cover:
The principles and benefits of clinically relevant specifications
Highlight the progress in the area over the last few years including Regulatory and Industry scientific meeting outputs
A cross Industry perspective and recommended roadmap on approaches for establishing CRDS for IR oral drug products.
Dr Paul Dickinson – SEDA Pharmaceutical Development Services
Paul A Dickinson BPharm (Hons) PhD
Director, Seda Pharmaceutical Development Services®
Paul is co-founder of Seda, a company providing pharmaceutical development and clinical pharmacology services and consultancy to the Pharma Industry.
Published in The Times and referenced in FDA draft guidance, Paul has held several senior science leadership roles in Academia and Large Pharma for over 20 years. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pre-clinical, pharmaceutical and clinical disciplines.
Paul has extensive early development, late development and drug registration stage experience including the delivery of several products to approval.
Paul has an international scientific reputation and is past Chair of the AAPS ‘QbD and product performance’ focus group. Paul has been at the forefront of recent technical and regulatory advances in performance criteria that assure drug product performance in the patient (clinically relevant specifications).
Dr Andreas Abend – MSD
Andreas Abend received his PhD degree in Organic Chemistry from the University of Karlsruhe in Germany. Prior to joining MSD as a Senior Project Chemist, Andreas spent 3 years as a Post-Doctoral Fellow at the University of Wisconsin’s Enzyme Institute. He is currently a Director in the Analytical Sciences department leading a group of scientists supporting new drug product development. Throughout his career at MSD, he supported small molecule API and drug product development spanning all clinical phases. Andreas is a member of Merck’s Biopharmaceutical Advisory Team, PQRI’s BTC, and a member of IQ’s Analytical Leadership Group. He presented at many national and international meetings, published several manuscripts on Clinically Relevant Dissolution specifications and he recently served as co-organizer of two workshops at the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
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